The latest from DTC Perspectives

DTC Insights' Alert:New Requirements for Print Ads

FLORHAM PARK , N.J. (February 26, 2008) — Marketers using “published” DTC ads in their media plans beginning March 25 are required to include specific information in the ads on how to report adverse events to the FDA, and this information must be printed “in conspicuous text.”

The new requirement, established in last year's FDA Amendments Act (FDAAA), affects only print ads at this time. The requirement is not applicable to Internet or television advertising, according to a DDMAC official, but the rules could change in the future.

Kristin Davis, deputy director of DDMAC, provided an update on the adverse-event reporting requirement at last week's Drug Information Association conference in New York. (See the required wording for this text at the bottom of this Alert.) Asked about the agency's recommended placement of this text within the print ad, which is not defined in FDAAA, Davis said:

• "To satisfy that requirement, we do consider it extraordinarily likely that it should be in the main body of the advertisement…. One place that would make a lot of sense is after you list your adverse events because it's about reporting adverse events."

There have been many questions about what types of advertising the requirement applies to, Davis acknowledged. She noted that the statute is specific to "published" advertising. "If it's a labeling piece, and considered that way or if it's not defined as advertising, then we don't consider [the statute] to apply, but you are certainly welcome to include the statement in those materials." With respect to broadcast ads, the FDA expects to conduct a study at some point in the future to determine whether this statement is appropriate to for TV advertisements.

"If we do decide that this is appropriate for TV ads, we will have to issue regulations requiring it to be in TV ads and also determining a reasonable length of time for displaying it," Davis said. Asked about enforcement plans and penalties for not complying with the statute as of March 25, Davis told DTC INSIGHTS, "It would be a violation [and] we could take action. But at this point, we're not ready to say we will."

DTC INSIGHT

* This new requirement technically is in effect for all magazines that carry April cover dates, although it seems unlikely DDMAC will issue violation letters on this requirement right out of the gate. Expect perhaps a minimum one-month grace period, but understand that there's a risk involved with any delay. For broadcast ads, given that there's a required study on the topic, it's unlikely such a requirement could be put in place before late 2009.

MORE INFORMATION: The wording of the required text for print ads is: "You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088."  

To view a copy of the FDA Amendments Act, click on the link below. This new requirement is outlined in Section 906, Title IX, of FDAAA. http://www.fda.gov/oc/initiatives/HR3580.pdf.